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NOT YET RECRUITING
NCT07784413
PHASE2

A Sequential Trial of Low-Dose Radiotherapy Followed by Concurrent Immunotherapy, Systemic Chemotherapy, and Intraperitoneal Perfusion in Gastric Cancer With Peritoneal Carcinomatosis

Sponsor: Zhejiang Cancer Hospital

View on ClinicalTrials.gov

Summary

This study is a prospective, single-center, open-label, exploratory phase II clinical trial aimed at evaluating the safety, tolerability, and preliminary efficacy of low-dose radiotherapy (LDR) sequentially combined with serplulimab, bevacizumab analog, and irinotecan or albumin-bound paclitaxel in patients with gastric cancer and peritoneal metastases. A total of 40 patients with gastric adenocarcinoma who have previously undergone first-line therapy are planned for enrollment. Patients will be grouped based on prior exposure to paclitaxel-based chemotherapy to determine whether they will receive systemic treatment with irinotecan combined with serplulimab or albumin-bound paclitaxel combined with serplulimab, along with local intraperitoneal infusion of bevacizumab analog. The study adopts a Simon two-stage design, with 20 patients enrolled in the first stage. If ≥3 patients achieve objective remission, the study will proceed to the second stage, enrolling an additional 20 patients.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-09-01

Completion Date

2029-07-30

Last Updated

2026-08-25

Healthy Volunteers

No

Interventions

DRUG

low-dose radiotherapy (LDR) sequentially combined with serplulimab, bevacizumab analog, and irinotecan or albumin-bound paclitaxel

low-dose radiotherapy (LDR) sequentially combined with serplulimab, bevacizumab analog, and irinotecan or albumin-bound paclitaxel

Locations (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China